2014 PDA/FDA Joint Regulatory Conference
Important Deadlines - Register before June 30 to receive the largest registration savings | Hotel Cutoff: August 15
Connecting Regulatory, Quality, Science & Compliance: Assuring Customer-Focused Outcomes throughout the Product Lifecycle
Sep 08 - Sep 10, 2014 | Renaissance Washington Hotel | Washington, DC
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September 8-10
September 10-11
September 11-12
Program Highlights
Just confirmed - Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, FDAImportant Deadlines - Register before June 30 to receive the largest registration savings | Hotel Cutoff: August 15
The PDA/FDA Joint Regulatory Conference offers the unique opportunity for you to join FDA representatives and industry experts in face-to-face dialogues. Each year, FDA speakers provide updates on the current state of efforts impacting the development of global regulatory strategies; while industry professionals from some of today's leading pharmaceutical companies present case studies on how they employ global strategies in their daily processes.
Hear directly from FDA experts and representatives of global regulatory authorities, and take home best practices for compliance.
Hear directly from FDA experts and representatives of global regulatory authorities, and take home best practices for compliance.
Learning Objectives
At the completion of this program, participants will be able to:- Understand the industry measures and regulatory expectation on the drug shortage issue currently facing patients the industry
- Examine approaches to managing supply chain concerns interruptions or crises related to their products
- How to effectively handle post inspectional follow-ups including responding to 483's or regulatory expectations and meeting requests
- Support identifying key performance indicators for measuring quality with in their company
- Understand the importance of a robust quality agreement and supplier oversight
- Define the issues and challenges of outsourcing activities
- Understand and articulate FDA's expectation for submissions
- Understand expectations on cGMPs for Active Pharmaceutical Ingredients (APIs)
- Describe the current thinking and regulatory framework regarding Good Distribution Practices (GDP)
- Apply the enhanced concepts of continual process validation stick to ICH terminology: 'process validation' or 'continued process verification' to their products and processes
- more information here
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